Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06319066
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-03-13
Brief Title:
Customized Foot Orthoses With Orthotic Wedges for Plantar Heel Pain
Sponsor:
Mahidol University
Organization:
Mahidol University
Study Overview
Official Title:
Effectiveness of Customized Foot Orthoses With Orthotic Wedges for the Treatment of Patients With Plantar Heel Pain
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The present study will use a randomized controlled trial RCT to determine the effectiveness of customized foot orthosis CFO for the treatment of patients with PHP Three treatment groups including the CFO without wedge the CFO with wedge type 1 W1 and the CFO with wedge type 2 W2 will be randomly assigned to each participant by a computer-generated randomization The opaque-sealed envelopes will be used to allocate the groups of participant
Detailed Description:
Participants will be allocated to the control CFO without wedge or experimental CFO with W1 or W2 groups according to the seal-envelop randomization technique Then they will be assessed all outcomes for the baseline including pain intensity foot function plantar fascia thickness balance outcomes and gait parameters by the 2nd physical therapist And the participants will receive the assigned treatment by the 1st physical therapist
All participants will be asked to use the CFO in daily life during weight-bearing activities and logbook chat LINE or phone call will be used to monitor the participants during the treatment program They will be asked about activity they done in daily and a number of hour they used CFO per day in diary book At least 4 hours per day of wearing CFO will be required to each participant After 3 months and 6 months of the CFO use all outcomes will be re-assessed by the 2nd physical therapist And such outcomes will be then statistically analyzed
All participants will be asked to use the CFO in daily life during weight-bearing activities and logbook chat LINE or phone call will be used to monitor the participants during the treatment program They will be asked about activity they done in daily and a number of hour they used CFO per day in diary book At least 4 hours per day of wearing CFO will be required to each participant After 3 months and 6 months of the CFO use all outcomes will be re-assessed by the 2nd physical therapist And such outcomes will be then statistically analyzed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None